# FDA 483 - The Phallofill Clinics LLC - August 08, 2025

Source: https://www.keypedia.com/records/483/the-phallofill-clinics-llc/f4b49f0e-5db0-4524-99ca-1857aa5428f6

> FDA 483 for The Phallofill Clinics LLC on August 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Phallofill Clinics LLC
- Inspection Date: 2025-08-08
- Product Type: device
- Office Name: Dallas District Office
- Summary: The Phallofill Clinics LLC in Dallas, TX, an initial importer/distributor of the Class II medical device PhalloSleeve, was cited with four observations during an FDA inspection. The firm failed to establish and implement critical quality system procedures, including those for Medical Device Reporting (MDR), complaint handling, corrective and preventive actions (CAPA), and finished device acceptance activities. These deficiencies indicate significant gaps in the firm's quality management system.

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)
- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/the-phallofill-clinics-llc/f8ff3300-9c8a-4e73-af24-dd58c0eedf5a

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9